ORIGINAL ARTICLE Braz J Cardiovasc Surg 2020;35(6):891-6

The New Surface Landmarks for Blind Axillary Puncture

Yaming Shi1, MD; Yongzhong Zong1, MD

DOI: 10.21470/1678-9741-2019-0422

Abstract Objective: To compare the efficacy of blind axillary vein Results: There were no significant differences between the two puncture utilizing the new surface landmarks for the subclavian groups in baseline characteristics or number of leads implanted. method. There were high success rates for both strategies (98.6% [494/501] Methods: This prospective and randomized study was vs. 98.4% [479/487], P=0.752) and similar complication rates performed at two cardiology medical centers in East China. Five (14% [38/272] vs. 15% [40/266], P=0.702). Six cases in the control hundred thirty-eight patients indicated to undergo left-sided group developed subclavian venous crush syndrome and five pacemaker or implantable cardioverter defibrillator implantation had pneumothorax, while neither pneumothorax nor subclavian were enrolled, 272 patients under the axillary access and 266 venous crush syndrome was observed in the experimental group. patients under the subclavian approach. A new superficial landmark Conclusion: We have developed a new blind approach to was used for the axillary venous approach, whereas conventional cannulate the axillary vein, which is as effective as the subclavian landmarks were used for the subclavian venous approach. We access, safer than that, and also allows to get this vein without measured lead placement time and X-ray time from vein puncture the guidance of fluoroscopy, contrast, or echography. until all leads were placed in . Meanwhile, the Keywords: Axillary Vein. Vena Cava, Superior. X-Rays. rate of success of lead placement and the type and incidence of Pneumothorax. Incidence, Control Groups. Crush Syndrome. complications were compared between the two groups. Prospective Studies. . Pacemaker, Artificial.

performed method for implanting endocardial pacemaker Abbreviations, acronyms & symbols and transvenous defibrillator leads[2]. However, a 1% to 3% AMI = Acute myocardial infarction incidence of pneumothorax or hemothorax has been reported AVB = Atrioventricular block in association with the subclavian access[3-5]. Additionally, the CRT = Cardiac resynchronization therapy subclavian access may result in an increased incidence of lead DCM = Dilated cardiomyopathy fracture due to entrapment of the lead by the costoclavicular ICD = Implantable cardioverter defibrillator ligament and/or the subclavius muscle[6,7]. Although blind ICM = Ischemic cardiomyopathy axillary venous access was proved to be safe by Belott[8], many LBBB = Left bundle branch block physicians still cannulate central under tools guidance. SPSS = Statistical Package for the Social Sciences The tools to facilitate cannulation, such as echography, are SSS = Sick sinus syndrome not available everywhere. Additionally, an expert in device SVC = Superior vena cava implantation should master every option so he or she can VT = Ventricular tachycardia choose the one that fits better in every situation.

METHODS INTRODUCTION From January 2012 to June 2014, all patients who presented Central venous access is an essential step during to the cardiology department of the Yancheng Third People’s pacemaker and implantable cardioverter defibrillator (ICD) Hospital and the Nanjing Gulou Hospital in East China with leads implantation[1]. Since first described in the late 1960s, indication to undergo left-sided pacemaker or ICD implantation the subclavian approach has emerged as the most frequently were included in this study. The patients with indication for

1Department of Cardiology, Yancheng Third People’s Hospital, Yancheng, Jiangsu, Correspondence Address: People’s Republic of China. Yaming Shi https://orcid.org/0000-0001-6508-0177 This study was carried out at the Department of Cardiology, Yancheng Third Department of Cardiology, Yancheng Third People’s Hospital People’s Hospital, Yancheng, Jiangsu, People’s Republic of China. no. 75 Juchang Road, Yancheng, Jiangsu, People’s Republic of China Zip Code: 224001 E-mail: [email protected] Article received on November 12th, 2019. Article accepted on January 7th, 2020.

891 Brazilian Journal of Cardiovascular Surgery Shi Y & Zong Y - The New Surface Landmarks for Blind Axillary Vein Puncture Braz J Cardiovasc Surg 2020;35(6):891-6

right-sided pacemaker or ICD implantation were excluded from this study. Any patient with indication for endocardial lead removal or upgrade was also excluded. Additionally, any patient who did not agree to participate in the study was excluded. All procedures followed our institutional guidelines and all patients provided their written informed consent. Patients’ demographics and clinical characteristics were recorded at baseline. Appling a simple randomized method, all patients were divided into experimental group and control group to receive implantation of endocardial electrode leads through axillary vein and subclavian vein approaches, respectively. The Research Ethics Committee of Yancheng Third People’s Hospital approved the study protocol (report of the ethics committee 2011-007). Left subclavian venipuncture was performed through the skin at the level of the costoclavicular ligament using a G18 puncture needle attached to extension tubing and 10 ml syringe. The needle was inserted under negative pressure into the vein, 1-2 cm away from the external-inferior part of 1/3 point of intersection of medial-middle clavicle. The needle has clung closely to the skin or formed an angle of 30° with the skin, with the needle tip pointing to the sternal fovea superior or the Adam’s apple. The withdrawal of venous confirmed that Fig. 2 – A subcutaneous generator pocket was created by an incision the needle had entered the vein; afterwards, a standard 50-cm through the puncture point. 0.038-inch J-tipped guide wire was then advanced through the needle to the superior vena cava (SVC), which was verified by X-ray fluoroscopy. A subcutaneous generator pocket was then The puncture method of the left axillary vein was as follows. created by an incision parallel to and approximately 2 cm below Firstly, the midpoint of the left clavicle (point C) was determined the clavicle. based on the position of both ends of the left clavicle (points A and B). Secondly, the connection between the middle point of left clavicle and the acromion (line of the segment BC) was used as the bottom margin of the regular triangle, and the vertex of the inverted regular triangle (point D) was determined as the puncture point (Figure 1). Thirdly, the left axillary vein approach was performed through the skin, the G18 puncture needle was positioned at a 60° angle to the plane of the skin and a 60° angle to the bottom margin of the regular triangle. The needle was then advanced under suction until the vein was entered, as shown by a flash of blood in the syringe. If unsuccessful, the needle was moved either medially or laterally and the maneuver was repeated until the vein was entered. A standard 50-cm 0.038-inch J-tipped guide wire was then advanced through the needle to the SVC, which was verified by X-ray fluoroscopy. Separate punctures were used for each lead. A subcutaneous generator pocket was then created by an incision through the puncture point (Figure 2). At least five unsuccessful punctures were necessary to define a failure of the axillary vein access. In case of failure of the axillary vein access, the subclavian Fig. 1 – Diagram highlighting the access obtained by the axillary vein or the cephalic vein was sought. The vein puncture was vein approach. The midpoint of the left clavicle (point C) was carried out by two implanters. Prior to this study, learning of a determined based on the position of both ends of the left clavicle blind axillary vein puncture technique was carried out by two (points A and B), and the connection between the middle point implanters. According to the learning curve theory, axillary vein of the left clavicle and the acromion (line of the segment BC) was puncture training was completed when procedural times of two used as the bottom margin of the regular triangle; the vertex of the implanters was stabile[9]. Within three months, two operators inverted regular triangle (point D) was determined as the puncture completed 30 cases (Figures 3 and 4). point. The G18 puncture needle is positioned at a 60° angle to the Lead placement time was measured from vein puncture plane of the skin and a 60° angle to the bottom margin of the regular until the fluoroscopic visualization of all leads in the SVC, and triangle. This diagram was modified from Ramza BM, et al.[5]. X-ray time was the time the fluoroscopic fluid used to reach

892 Brazilian Journal of Cardiovascular Surgery Shi Y & Zong Y - The New Surface Landmarks for Blind Axillary Vein Puncture Braz J Cardiovasc Surg 2020;35(6):891-6

this endpoint. The safety and effectiveness of the new surface landmarks for blind axillary vein puncture described in this study were evaluated by comparing the rate of success of lead placement and the type and incidence of complications. Chest X-ray film was obtained immediately after the procedure and in the following day to rule out evidence of pneumothorax and to check lead location. All participants were regularly followed up seven days, one month, and three months after the procedure, and then at intervals of one year at the device clinic in two hospitals. At each follow-up visit, generator and lead statuses, including fractures, insulation defects, and infections, subclavian or axillary vein , and sensing and pacing parameters were examined. Numerical variables are presented as median and standard deviation. Data were compared using Students’ paired t-test. Categorical variables, expressed as numbers and percentages, were compared using Chi-square or Fisher’s exact test. All statistical analyses were performed using the Statistical Package Fig. 3 – Time to place the leads in the superior vena cava for for the Social Sciences (SPSS) software (SPSS Inc, Chicago, Illinois, Operator 1. United States of America), version 13.0.

Patient and Public Involvement This research project was constructed without patient involvement. Patients were not invited to comment on the study design and were not consulted to develop patient relevant outcomes or to interpret the results. Patients were not invited to contribute to the writing or editing of this document for readability or accuracy.

RESULTS There were 272 cases in the experimental group, including 176 males and 96 females, with age of 71.8±9.5 years; meanwhile, 266 cases were enrolled into the control group, including 171 males and 95 females, with age of 72.7±7.9 years. Differences in sex and age between the two groups were not statistically significant (P>0.05). The indication for pacemaker implantation was sick sinus syndrome in 238 patients and third- degree atrioventricular block in 176 patients. Of the 51 patients undergoing cardiac resynchronization therapy implantation, Fig. 4 – Time to place the leads in the superior vena cava for 28 had dilated cardiomyopathy with complete left bundle Operator 2. branch block (LBBB) and 33 had ischemic cardiomyopathy (ICM) with complete LBBB. Of the 73 patients who underwent ICD implantation, 32 had ventricular tachycardia (VT) 40 days after Among the four cases with unsuccessful puncture in the acute myocardial infarction and 41 had non-ICM complicated experimental group, three were changed to implantation of with VT. Five hundred and one endocardial electrode leads endocardial electrode leads through the ipsilateral subclavian were implanted through the axillary vein approach in the venipuncture, while one was changed to implantation of experimental group, and 487 endocardial electrode leads endocardial electrode leads through the contralateral subclavian were implanted through the subclavian vein approach. The venipuncture. All five cases with unsuccessful puncture in the difference in the disease type between the two groups was not control group were changed to implantation of endocardial statistically significant (P>0.05), as shown in Table 1. There were electrode leads through the contralateral subclavian vein. Five no differences of lead placement time and X-ray time between cases in the control group had pneumothorax after surgery, and the two groups (2.30±1.93 minutes vs. 2.08±1.11 minutes and six had endocardial electrode lead rupture due to subclavian vein 51.3±10.4 seconds vs. 54.6±11.7 seconds, respectively). The crush syndrome. One case in the experimental group had right successful puncture rates in the experimental and control ventricular electrode perforation and one had SVC syndrome. groups were 98.6% (494/501) and 98.4% (479/487), respectively. Seven cases in the experimental group and eight in the control

893 Brazilian Journal of Cardiovascular Surgery Shi Y & Zong Y - The New Surface Landmarks for Blind Axillary Vein Puncture Braz J Cardiovasc Surg 2020;35(6):891-6

group suffered from electrode dislocation, which was adjusted DISCUSSION again through the original vein approach. Additionally, 10 cases Central venous access is an essential step during pacemaker in the control group and 12 in the experimental group had and ICD leads implantation. The main approaches are subclavian, pouch hematomas, which subsided after pressure bandaging. axillary, and cephalic accesses. Among those, the subclavian Moreover, eight cases in the experimental group and three in approach is the more frequently performed[10], although it carries the control group had left upper extremity ; several risks, mainly lead fracture because of entrapment with among them, two in the experimental group improved after oral the surrounding tissues (as high as 7%, according to Migliore et administration of warfarin and another three recovered after al.[10]), and a higher incidence of pneumothorax (1-3% vs. 0-1% subcutaneous injection of low molecular weight heparin, while of the axillary approach[10-11]). Cephalic vein access is very safe the remaining three in the experimental group as well as three for both the electrode and the patient[12], however it is more in the control group recovered spontaneously two weeks after time consuming and technically challenging, especially when surgery by means of left upper extremity activity to promote the more than one electrode are to be implanted. On the other construction of collateral circulation. Comparisons between the hand, the axillary approach combines both safety and a high results of both groups were shown in Table 2. success rate. Compared with the subclavian vein approach, the

Table 1. Basic characteristics of patients in the two venous access groups. Experimental group, Control group, Grouping category P-value n (%) n (%) Number of patients 272 266 SSS 127 (46.7) 111 (41.7) 0.247 AVB 85 (31.3) 91 (34.7) 0.464 DCM with LBBB 13 (4.8) 15 (5.6) 0.654 ICM with LBBB 11 (4.0) 12 (4.5) 0.789 AMI with VT 17 (6.5) 15 (5.6) 0.765 ICM with VT 19 (7.0) 22 (8.3) 0.574 There were non-significant differences between the groups AMI=acute myocardial infarction; AVB=atrioventricular block; DCM=dilated cardiomyopathy; ICM=ischemic cardiomyopathy; LBBB=left bundle branch block; SSS=sick sinus syndrome; VT=ventricular tachycardia

Table 2. Comparison between the results of the two venous access groups. Experimental group, Control group, Grouping category P-value n (%) n (%) Number of patients 272 266 Lead placement time (minutes) 2.30±1.93 2.08±1.11 0.109 X-ray time (seconds) 51.3±10.4 54.6±11.7 0.327 Successful puncture rate 494/501 (98.6) 479/487 (98.4) 0.752 Pouch hematomas 12 (4.4) 10 (3.8) 0.702 Left upper extremity venous thrombosis 8 (2.9) 3 (1.1) 0.137 Pouch infection 9 (3.3) 8 (3.0) 0.770 Electrode dislocation 7 (2.6) 8 (3.0) 0.754 Pneumothorax 0 (0.0) 5 (1.9) 0.029 Subclavian vein crush syndrome 0 (0.0) 6 (2.3) 0.014 Right ventricular electrode perforation 1 (0.4) 0 (0.0) 0.322 Superior vena cava syndrome 1 (0.4) 0 (0.0) 0.322 Global complications 38 (14.0) 40 (15.0) 0.725

894 Brazilian Journal of Cardiovascular Surgery Shi Y & Zong Y - The New Surface Landmarks for Blind Axillary Vein Puncture Braz J Cardiovasc Surg 2020;35(6):891-6

axillary venipuncture approach is associated with the following No financial support. advantages. Firstly, the axillary venipuncture approach is not likely to induce crush syndrome due to the great distance when No conflict of interest. the endocardial electrode passes through the clavicle and the first intercostal spaces[13]. Secondly, the axillary vein runs outside the thoracic projection, and the puncture needle can form a certain angle with the thoracic wall, which is not likely to induce pneumothorax. Thirdly, the axillary vein is far away from the Authors' roles & responsibilities continued posterior and the subclavian vein, which can reduce the possibility of mistaken arterial puncture. YS Design of the study; final approval of the version to be Blind axillary venous access was described several years published ago[8], but it is rarely used in a blind manner because of safety YZ Acquisition of data; drafting the work; final approval of concerns[14], although only one pneumothorax has been the version to be published described by Belott[15] after 168 implanted electrodes (0.6%). Nowadays, the axillary vein is canalized mainly with fluoroscopic or ultrasonic guidance[9,16-18]. However, these methods are time consuming in operation and will increase the costs, which are not appropriate for promotion and can only be used in some special REFERENCES conditions, such as venous malformation and failure in repeated puncture. Moreover, the body surface positioning methods 1. 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896 Brazilian Journal of Cardiovascular Surgery